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RecruitingPhase 4interventionalRules rewrite

Phase 4: testing SGLT2 inhibitor (Dapagliflozin 10mg) for Congenital Heart Disease

Repaired Tetralogy of Fallot (rTOF) is the leading cause of congenital cyanotic heart disease worldwide, involving up to 7-10% of congenital heart disease. With advances in open-heart surgical repair techniques and medical therapies, there is a significant increase in patients with rTOF surviving till late adulthood.

Official registry: https://clinicaltrials.gov/study/NCT06668389 · The University of Hong Kong · enrollment listed as 106

What this phase means

Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are SGLT2 inhibitor (Dapagliflozin 10mg). The registry lists allocation as randomized. Repaired Tetralogy of Fallot (rTOF) is the leading cause of congenital cyanotic heart disease worldwide, involving up to 7-10% of congenital heart disease.

They plan to enroll about 106 people at Hong Kong. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Sodium-Glucose Cotransporter 2 Inhibitors for Repaired Tetralogy of Fallot Patients for Enhancement of Cardio-Pulmonary Status Trial (STEPS Trial)

Interventions: SGLT2 inhibitor (Dapagliflozin 10mg)

Primary outcome (registry wording): Maximal oxygen uptake (VO2 max) on cardiopulmonary exercise (CPX) at 3 months

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Aged 18 years or above

Public study contact (from the registry)

Chun Ka Dr Wong, Clinical Assistant Professor

+852-22553111

wongeck@hku.hk

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT06668389 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06668389?

Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06668389?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary